MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3544700
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	12/08/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: capsular contracture baker grade iv, generalized illness and surgical intervention.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent breast augmentation revision surgery with 700cc mentor memorygel breast implants experienced bilateral capsular contracture baker grade iv, chronic pain, scar tissue, inability to perform adls, burning sensation underneath and around areola, back pain and deformity in implants post procedure.As a result, patient has a planned explantation on (b)(6) 2020.In 2017, patient underwent a surgical procedure to re-position the right and left breast implants.The right and left breast implants were re-used.Per mentor ifu, these devices are for single use only and should not be re-implanted.Therefore, these devices were used off label.This report is for the right sided device.See 1645337-2019-25601 for contralateral prosthesis report.
Additional Manufacturer Narrative
On 3/10/2020, the mentor failure analysis lab received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 11/20/2020.Device evaluation summary: according to the information reported, the patient experienced bilateral capsular contracture, chronic pain, scar tissue, inability to perform adls, burning sensation underneath and around the areola, back pain, and deformity in implants post-procedure.Additionally, the patient underwent a surgical procedure to re-position the right and left breast implants.Both were re-used.During visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.Per mentor instructions for use (ifu), these devices are for single use only and should not be re-implanted.Therefore, both devices were used off label.At the present time, there is no sufficient evidence to show an association between breast implants and generalized illness (assessing the risks of breast implants and fda¿s vision for the national breast implant registry).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9459030
• Report Number: 1645337-2019-25602
• Device Sequence Number: 2158939
• Product Code: FTR
• UDI-Device Identifier: 00081317001157
• UDI-Public: 00081317001157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2020
• Device Model Number: 3544700
• Device Catalogue Number: 3544700
• Device Lot Number: 6938562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 03/10/2020; 11/20/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/30/2020; 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR